Trial record 5 of 61 for:    BUTYRYLCHOLINESTERASE

Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

This study has been completed.
Sponsor:
Collaborator:
University of Toronto
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00482001
First received: May 31, 2007
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

The goal of the study is to assess the role of cholinesterase inhibitors in affecting the driving ability of cognitively intact seniors using driving simulators. We hypothesize that the use of a cholinesterase inhibitor for two weeks will be associated with improvement in safe driving behavior on a simulated driving task.


Condition Intervention Phase
Mental Health
Geriatrics
Drug: donepezil
Drug: Placebo (cornstarch)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • General performance and errors made on a computer-simulated driving test [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: donepezil
donepezil 5mg, once daily for 2 weeks
Other Name: Aricept
Placebo Comparator: 2 Drug: Placebo (cornstarch)
1 capsule daily for 2 weeks

Detailed Description:

Alzheimer's disease (AD) is the most common cause of dementia, and while it is known that AD poses substantial risks of motor vehicle collisions, many people in the earliest stages of AD continue to drive. Memory problems themselves are poor predictors of who is actually unsafe on the road, and various medications that are used to treat people with AD may impact on their driving abilities. Donepezil is a drug used to treat the memory problems associated with AD. While previous studies have shown that it slows the decline of activities of daily living (eg. shopping, banking, dressing) and may improve the ability of younger pilots to perform on computerized flight simulators, no studies have examined the impact of donepezil on driving abilities in older adults.

The present investigation is a pilot study aiming to determine if donepezil helps healthy older drivers perform on driving simulators. Two Canadian academic centers have different driving simulators - one in Toronto and one in Thunder Bay. At each of these centers, ten healthy men aged 65 to 75 will be randomly assigned to receive either donepezil 5mg/day or identical placebo for two weeks.

Using the driving simulator, we will assess various aspects of driving ability. These measures of driving performance will be compared between those who received the drug and those who received the placebo.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • valid Ontario driver's license
  • active driver (greater than or equal to three times per week)
  • written, informed consent
  • lives in Toronto/Thunder Bay
  • healthy
  • Male between 65-75 years old

Exclusion Criteria:

  • cognitive impairment
  • psychiatric history
  • sleep disorder history
  • substance abuse
  • neurological history
  • medical illness
  • ophthalmological disease
  • psychoactive medications
  • contra-indications to Donepezil
  • experience car/motion sickness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482001

Locations
Canada, Ontario
Lakehead University
Thunder Bay, Ontario, Canada, P7B 5E1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University of Toronto
Investigators
Principal Investigator: Mark Rapoport, MD, FRCPC University of Toronto
Study Chair: Michel Bedard, PhD Lakehead University
Study Chair: Nathan Herrmann, MD, FRCPC University of Toronto
Study Chair: Krista Lanctot, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Mark J Rapoport, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00482001     History of Changes
Other Study ID Numbers: 458970
Study First Received: May 31, 2007
Last Updated: February 5, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Donepezil
Driving
Cholinesterase Inhibitors
Geriatric Psychiatry
Psychopharmacology
Aricept

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014